bta beaten to the bird flu punch by csl, page-6

Carol:
Really nothing anti BTA - they still have a very valuable anti viral. CSL hasn't put it to the TGA - 'maybe by the end of the year' - it's all old news.
CSL confident bird flu vaccine is safe
Friday Feb 17 15:13 AEDT
A vaccine against the deadly bird flu virus could be available in Australia within six weeks of a pandemic, according to the drug's manufacturer.

Melbourne-based pharmaceutical manufacturer CSL Ltd released early results of clinical trials and is confident the vaccine is safe and effective.

CSL chief scientific officer Dr Andrew Cuthbertson said while the drug could be used in the event of a health crisis with special permission, further research was needed before the vaccine was formally approved.


"What we do know is if a pandemic were hypothetically declared and we had to respond, then government would instruct us to do that," Dr Cuthbertson told reporters.

"We would be able to be producing vaccine within six weeks."

But CSL principal investigator Professor Terry Nolan warned the vaccine - developed from a strain taken from a Vietnamese bird flu victim - may not provide immunity in the event that the H5N1 virus mutates and becomes highly infectious between people.

"This vaccine has been designed around a known case of avian flu but when and if that mutation ... occurs the genetic sequence will change," he said.

If that happens the "clock starts ticking" for researchers to modify the vaccine.

The vaccine is the only one of its type under development in the southern hemisphere and could prove a powerful weapon in the fight against bird flu, which has so far infected more than 160 people in Asia and the Middle East.

Almost 100 have died.

Prof Terry Nolan said a pandemic was inevitable and that it was critical the vaccine was developed in small doses so that it could be mass produced in readiness for a public health crisis.

"There's a high possibility of something happening with H5N1, that's why we're taking it so seriously," he said.

The first trial of a prototype vaccine started in October at the Murdoch Children's Research Institute in Melbourne and involved 400 volunteers aged between 18 and 45.

In the first trial volunteers were administered two doses of either 7.5 or 15 micrograms of the vaccine two weeks apart with a immunity boosting agent.

The research found the vaccine was effective in immunising people against bird flu, was safe and had few side effects.

The next study will involve 800 people, including about 200 children as young as six months and the elderly.

It will trial doses as high as 30 micrograms and 40 micrograms to measure the vaccine's effectiveness and longevity.

In the meantime, CSL hopes to stockpile antigen - the active ingredient in the vaccine - in preparation for a pandemic.

"This is not an elective issue, this is a crisis which we're all facing and we must be properly prepared for it," Prof Nolan said.